Immunogenicity and safety of the booster BNT162b2 vaccine in patients with axial spondyloarthritis treated with biological disease-modifying drugs
Abstract
BACKGROUND: Vaccination confers relatively short-term protection against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), indicating the need for booster doses. Immunocompromised individuals, including those with immune-mediated inflammatory diseases (IMIDs), may have pronounced immune response waning.
Vaccine-boosted humoral and T-cell responses minimize poor coronavirus disease 19 (COVID-19) outcome without increasing adverse events (AE). There is limited evidence of third-dose vaccination in axial spondyloarthritis (AxSpA) patients.
We investigated immune-response persistence after primary vaccination and immunogenicity and safety after the BNT162b2 booster vaccination. METHODS: This prospective observational study enrolled an AxSpA cohort treated with interleukin-17 (IL-17) and tumor necrosis factor-alpha (TNFα) inhibitors.
Serum SARS-CoV-2-specific and virus-neutralizing antibodies for humoral response and flow cytometric detection of intracellular cytokines following SARS-CoV-2-specific peptide-based stimulation for T-cell immune responses were assessed, and safety was evaluated via a clinical questionnaire. RESULTS: Fifteen male AxSpA patients treated with TNFα (73.3%) or IL-17 (26.7%) inhibitors were enrolled and had humoral response persistence at 6 months: 905.6 ( +- 186.1 SD) and 409.1 ( +- 335.7) U/mL.
Specific antibody concentrations further increased after booster vaccination to 989.7 ( +- 12.62) and 1000 U/mL and T-cell responders from 53.3% to 80%, with no differences between AxSpA (including "vaccination only" and "hybrid immunity" subgroups) and healthy control (HC) cohorts. No severe AE occurred; the AE spectrum was comparable to that of the general population.
CONCLUSION: Immune-response persistence after primary vaccination and immunogenicity after booster vaccination were unaffected by anti-IL17 or anti-TNFα therapy with similar AE as in the general population.